ACE Acetabular Cup UK Multi-centre PMCF Study

Recruiting now

Conditions studied: Hip Disease

In brief

A total hip replacement is one of the most successful and cost-effective surgical procedures in orthopaedics, and involves replacing both the hip ball and socket. Its goal is to provide pain relief, allowing the person to return to a normal lifestyle. JRI Orthopaedics have developed the ACE Acetabular Cup System, which has a H-A.C. coating to promote ossoeintegration of the device within the host bone. To increase the surgeons choice and thus suitability for the patient, there is the option of 3 different socket liners (ceramic, polymer or dual mobility). To ensure maximum safety and performance of medical devices surveillance of the device should be carried out over the devices lifetime. This study is a 10 year surveillance study to assess the clinical, functional and radiological outcomes of the CE-marked ACE Acetabular Cup System. This is done by examining patient outcomes through questionnaires, reviews of X-rays and complications by patients who have received a total hip replacement using the ACE Acetabular Cup System at participating sites.

Key facts

Study ID

NCT04123431

Run by

JRI Orthopaedics

People needed

225

Starts

2023-06-06

Expected to finish

2035-11-01

Last updated by the study team

2025-09-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients deemed suitable for elective primary THR, as per indications in the IFU.
• Male or female, 18 years or older.

You may not qualify if…

• Patients who are unable to provide written informed consent.
• Patients deemed unsuitable for THR, as per contra-indications in the IFU.
• Patients indicated for THR as a result of trauma (i.e. neck of femur fracture).
• Patients who are pregnant (exclusion criteria for THR in general).
• Patients receiving implants other than the approved combination, i.e. an ACE Acetabular Cup System with a JRI femoral stem and head.
• Patients who are unable to comply with the protocol.

Where it is running

• University Hospitals Sussex NHS Foundation Trust — Worthing, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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